Nationwide Uniform Scientific Evaluation of Flexible and Integrated Treatment Projects From 2022 Onwards
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FIT model project.
- Who it may be relevant to
- Registry conditions: Mental Health, Cross-sectoral Treatment, Flexible and Integrated Treatment, FIT. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Bundesweit Einheitliche Wissenschaftliche Evaluation Von Modellvorhaben Nach § 64b SGB V ab 2022
Overview
This study is an evaluation of flexible and integrated psychiatric care models (according to § 64b of the German Social Code Book V (SGB V)) (FIT) including new FIT projects starting after 2022 and the prolongation of any of 19 already established FIT projects (mainly at German psychiatric hospitals). The central concern of this evaluation is to answer the question whether FIT care offers advantages over standard care. The orientation of model care is a more cross-sectoral provision of services through more flexible psychiatric treatment intensities. However, FIT program structures depend on the individual situation and organization of the FIT hospital together with the participating statutory health insurance (SHI) funds.
Detailed description
The introduction of Section 64b of the German Social Code, Book V (SGB V) created the possibility of agreeing so-called FIT (flexible and integrated treatment) model projects for the further development of care for mentally ill people in Germany. The objective is to improve cross-sectoral care or optimize patient care. More than 20 FIT projects have been established at German psychiatric hospitals since 2013. Some FIT projects were prolonged after eight years (max. 15 years in sum). New FIT projects are planned.
In accordance with § 65 SGB V, all FIT projects under § 64b SGB V, must be scientifically evaluated by an independent expert. The aim of this evaluation is to examine the achievement of the objectives of the FIT model projects based on anonymized claims data.
The effectiveness, costs, and cost-effectiveness of the FIT model hospital care compared to standard care are to be examined. FIT projects include those starting before 2022 and being prolonged and those FIT projects starting between 2022 and June 2026. The study presented here is a controlled cohort study utilizing anonymous claims data. The controlled design is based on the fact that information of patients from intervention hospitals (any FIT design) is compared to information of comparable patients from structurally similar psychiatric hospitals in the same federal state (Petzold et al, Gesundheitswesen 2019, 81(1):63-71).
Interventions
- Other FIT model project
Several statutory health insurance (SHI) funds have established contracts with hospitals for an alternative remuneration / financing of patients treated in the hospital (FIT hospital). Some of those contracts already started in 2013 and were prolonged. Some FIT contracts will start freshly (until June 2026). These contracts encourage FIT hospitals to test alternative treatment options for their patients (insured with the involved SHI funds), for example fewer inpatient and more outpatient treatm
Primary outcome measures
- Duration of inpatient psychiatric treatment [Time frame: one year prior to recruitment compared to first to max year after recruitment. Max year = latest possible year for maximal observation period depending on the length of FIT project]
- Sick leave days [Time frame: one year prior to recruitment compared to first to fourth year after recruitment]
Secondary outcome measures (11)
- Duration of day care psychiatric treatment [Time frame: one year prior to recruitment compared to first to max year after recruitment]
- Outpatient psychiatric treatment (within and outside the hospital) [Time frame: one year prior to recruitment compared to first to max year after recruitment]
- Continuity of care [Time frame: one year prior to recruitment compared to first to max year after recruitment]
- Inpatient hospital readmission [Time frame: one year prior to one year after first full inpatient psychiatric discharge after recruitment]
- Discontinuation of contacts for severely mentally ill patients within the psychiatric care system [Time frame: one year prior to one year after recruitment]
- Hopping [Time frame: one year prior to recruitment compared to first to max year after recruitment]
- Comorbidities [Time frame: one year prior to recruitment compared to first to max year after recruitment]
- Mortality [Time frame: event time analysis]
- Disease progression [Time frame: event time analysis]
- Direct medical care costs [Time frame: one year prior to recruitment compared to first to max year after recruitment]
- Cost-effectiveness (direct medical costs) [Time frame: one year prior to recruitment compared to first to max year after recruitment]
Eligibility criteria
Inclusion criteria
- treatment in any of the participating hospitals or control hospitals within recruitment phase (number of hospitals will be fix until June 2026)
- being insured with any of the participating SHI funds
Exclusion criteria
- less than one year follow-up data available
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Institute for Social Medicine and Health System Research (ISMG), Medical Faculty, Otto-von — Magdeburg
Publications
- Petzold T, Neumann A, Seifert M, Kuster D, Pfennig A, Weiss J, Hackl D, Swart E, Schmitt J. [Identification of Control Hospitals for the Implementation of the Nationwide and Standardized Evaluation of Model Projects According to section sign 64b SGB V: Analysis of Data from Structured Quality Reports]. Gesundheitswesen. 2019 Jan;81(1):63-71. doi: 10.1055/s-0042-116436. Epub 2016 Nov 15. German. PMID 27846670
Identifiers
NCT: NCT05855720 · EVA64.2